Transforming MedTech: The Impact of the EU AI Act

August 1, 2024: The European Union’s Artificial Intelligence Act (EU AI Act—Regulation EU 2024/1689) entered into force.

Why This Matters: The Significance of the EU AI Act

• An essential regulation for digital healthcare products, impacting all AI/ML (Artificial Intelligence/Machine Learning) devices and systems, including stand-alone software as medical devices (SaMD) and complex hardware-software combinations;
• The introduction of new rules for the Medtech industry, highlighting the new obligations related to healthcare solutions.

How to Approach with Diverse Regulatory Frameworks?

The EU MDR and the EU IVDR currently regulate medical devices and IVD, which require dedicated compliance standards.

The EU’s AI Act introduces new layers of complexity for the medical device industry: AI systems medical devices are classified as “high-risk,” which is the highest risk classification even if the medical device falls in Class I (MDR) or Class A (IVDR). This means that risk management is crucial to handling correctly the entire lifecycle of digital healthcare products.

AI Act sets specific obligations for companies providing high-risk systems (Art.16), such as:

• Having a quality management system (Article 17)
• Keeping the documentation for 10 years after the system is released (Article 18)
• Ensuring that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43 before its being placed on the market or put into service
• Complyingwith the registration obligations referred to in Article 49(1)
• Ensuring that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.

Many of these align closely with the conformity assessment procedures already in place under MDR and IVDR handled by Notified Bodies; however, the precise requirements for this combined assessment process have yet to be defined. This means that no Notified Body can currently perform assessments under the AI Act.

Some of the rules included in the EU AI Act are close to the MDR/IVDR. However some will be linked explicitly to AI technology, such as:

• Data and data governance (Article 10)
• Record-keeping (Article 12)
• Automatically generated logs keeping (Article 19)
• Transparency (Article 13)
• Human oversight (Article 14)

Action Plan: Steps for Manufacturers

• Requirements Assessment: Perform a gap analysis against EU AI Act requirements to gain an overview of your AI-based medical device’s impact.
• Compliance Strategy: Define a compliance strategy considering MDR/IVDR requirements, including anticipated AI Act obligations.
• MDR/IVDR Compliance: Ensure that your current AI medical devices are fully compliant with MDR/IVDR. This will support the transition to the AI Act’s requirements when they become applicable.
• Updates: Stay informed about the evolving regulatory landscape to ensure compliance with this new framework.

Implementation Timeline: Important Dates to Remember

• 2nd August 2024 – AI Act enters into force
• 2nd February 2025
  • Chapter I: General Provisions
  • Chapter II: Prohibitions on AI practices
• 2nd August 2025
  • Chapter III Section 4: Notifying Authorities and Notified Bodies
  • Chapter V: Obligations for providers of general-purpose AI models
  • Chapter VII: Governance structure (including AI Office, AI Board, etc.)
  • Chapter XII: Penalties provisions (except fines for providers of GPAI)
  • Article 78: Confidentiality obligations
• 2nd August 2026 – Main provisions of the regulation become applicable
• 2nd August 2027 – Article 6(1) and the corresponding obligations: obligations related to high-risk AI systems that are safety components or components of products covered by Union harmonization legislation

About ProductLife Group

ProductLife Group aims to support patient access to safe and effective healthcare solutions by delivering worldwide consulting and outsourcing services throughout the entire product life. Combining local expertise with a global reach spanning more than 150 countries, PLG is the Life Sciences Industries reference strategic partner for the development, market introduction, and life cycle management of product portfolios and related business and digital transformation. With a goal of continuously improving the value delivered to teams and clients, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.

Contact us to guide you through EU AI Act requirements.

Author:

Arianna Dalla Ba

Medical Device Manager

ProductLife Group

Dr. Gabriele Breda

PhD, Research and Innovation Director

ProductLife Group

References

1. Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance) PE/24/2024/REV/1, OJ L, 2024/1689, 12.7.2024.